Product Code: KPR FDA class 2 21 CFR 892.1680

System, X-Ray, Stationary

Radiology

This device is a stationary x-ray system used for diagnostic imaging across a wide range of clinical applications including skeletal, thoracic, and abdominal radiography. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KPR, regulated under 21 CFR 892.1680 within the Radiology specialty. This device is eligible for third-party review.

View on FDA

510(k)s

356

FEI Numbers

Registration Numbers

Unique Applicants

163

Years Active

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Basic Information

Product Code: KPR
Device Class: FDA class 2
Regulation Number: 892.1680
Medical Specialty: Radiology
Review Panel: RA
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 356 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260482	DRE Duo	Jun 15, 2026	Substantially Equivalent	Jpi Healthcare Co, Ltd.
K253446	AeroDR TX c02	Apr 10, 2026	Substantially Equivalent	Dk Medical Systems Co., Ltd.
K250954	DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector	Jan 20, 2026	Substantially Equivalent	Carestream Health
K252000	uDR Arria & uDR Aris	Nov 26, 2025	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K251167	uDR Aurora CX	Sep 19, 2025	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K250788	Definium Tempo Select	Aug 28, 2025	Substantially Equivalent	Ge Hualun Medical Systems Co. , Ltd.
K250790	INNOVISION-DXII	Aug 01, 2025	Substantially Equivalent	Dk Medical Systems Co., Ltd.
K250738	YSIO X.pree	Jul 31, 2025	Substantially Equivalent	Siemens Medical Solutions
K242019	GXR-Series Diagnostic X-Ray System	Jan 07, 2025	Substantially Equivalent	DRGEM Corporation
K242499	Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))	Jan 06, 2025	Substantially Equivalent	Shenzhen Sontu Medical Imaging Equipment Co., Ltd.
K242119	INNOVISION-EXII	Jan 03, 2025	Substantially Equivalent	Dk Medical System
K241068	uDR 780i	Nov 01, 2024	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K242847	EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM); EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXi (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA);	Oct 23, 2024	Substantially Equivalent	DRTECH Corporation
K242678	Definium Pace Select ET	Oct 01, 2024	Substantially Equivalent	Ge Hualun Medical Systems Co. , Ltd.
K242478	GF85 (models GF85-3P, GF85-SP)	Sep 19, 2024	Substantially Equivalent	Samsung Electronics Co., Ltd.
K233920	EOSedge	Aug 06, 2024	Substantially Equivalent	Eos Imaging
K233530	EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM)	Jul 26, 2024	Substantially Equivalent	DRTECH Corporation
K233662	Radiography 7300 C	Jun 13, 2024	Substantially Equivalent	Philips Medical Systems Dmc GmbH
K233543	YSIO X.pree	May 21, 2024	Substantially Equivalent	Siemens Medical Solutions
K233719	FDR Visionary Suite	Mar 28, 2024	Substantially Equivalent	Shimadzu Corporation
K233381	DRX-Evolution Plus System	Mar 12, 2024	Substantially Equivalent	Carestream Health, Inc.
K233722	RADspeed Pro	Feb 23, 2024	Substantially Equivalent	Shimadzu Corporation
K233532	MULTIX Impact E	Nov 29, 2023	Substantially Equivalent	Siemens Medical Solutions
K230800	XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50	Nov 02, 2023	Substantially Equivalent	GEMSS HEALTHCARE CO., LTD.
K231761	PodSKAN HF Diagnostic X-ray System	Oct 27, 2023	Substantially Equivalent	Skanray Technologies Limited
K231995	AcuityUDR	Oct 25, 2023	Substantially Equivalent	Radmedix, LLC
K232178	GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)	Sep 19, 2023	Substantially Equivalent	DRGEM Corporation
K231892	Definium Pace Select	Sep 12, 2023	Substantially Equivalent	Ge Hualun Medical Systems Co. , Ltd.
K223550	DMX	Apr 10, 2023	Substantially Equivalent	Del Medical, Inc.
K230241	Jumong General	Feb 23, 2023	Substantially Equivalent	Sg Healthcare Co, Ltd.
K223842	DRX - Compass	Jan 20, 2023	Substantially Equivalent	Carestream Health, Inc.
K223060	DigiX FDX	Oct 26, 2022	Substantially Equivalent	Allengers Medical Systems Limited
K221853	OTC DDR	Jul 27, 2022	Substantially Equivalent	Konica Minolta Healthcare Americas, Inc.
K220919	MULTIX Impact E	May 17, 2022	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K220271	Hand Diagnostic Radiography Imaging System	Apr 29, 2022	Substantially Equivalent	Nanoray Biotech Co., Ltd.
K220149	General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K)	Apr 19, 2022	Substantially Equivalent	Xera Medical Systems & Technology , Ltd.
K220518	SKANRAD 400	Apr 01, 2022	Substantially Equivalent	Skanray Technologies Limited
K213057	ExamVue Duo	Feb 18, 2022	Substantially Equivalent	Jpi Healthcare Co, Ltd.
K214012	Straight Arm DDR	Jan 12, 2022	Substantially Equivalent	Konica Minolta Healthcare Americas, Inc.
K213700	MULTIX Impact, MULTIX Impact C	Dec 13, 2021	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K212186	Philips Radiology Smart Assistant	Dec 13, 2021	Substantially Equivalent	Philips Medical Systems Dmc GmbH
K210692	DigitalDiagnost	Apr 02, 2021	Substantially Equivalent	Philips Medical Systems Dmc GmbH
K203537	Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems	Feb 01, 2021	Substantially Equivalent	Sedecal., Sa.
K203345	MULTIX Impact	Jan 07, 2021	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K203340	MULTIX Impact C	Jan 06, 2021	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K202388	Apolo D / Apolo S	Dec 01, 2020	Substantially Equivalent	Vmi Tecnologias Ltda
K201825	MiniCAT 2D	Nov 20, 2020	Substantially Equivalent	Xoran Technologies, LLC
K201670	YSIO X.pree	Oct 21, 2020	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K202293	Radiographic System Challenge X	Oct 07, 2020	Substantially Equivalent	Sedecal., Sa.
K202572	GXR-Series Diagnostic X-Ray System	Sep 24, 2020	Substantially Equivalent	DRGEM Corporation
K202394	EOSedge	Sep 16, 2020	Substantially Equivalent	Eos Imaging
K202156	DIAMOND-5A/6A/8A	Sep 10, 2020	Substantially Equivalent	DRGEM Corporation
K201725	DigitalDiagnost C50	Jul 10, 2020	Substantially Equivalent	Philips Healthcare (Suzhou) Co., Lit.
K201640	DuraDiagnost	Jul 09, 2020	Substantially Equivalent	Philips Healthcare (Suzhou) Co., Ltd.
K201373	DRX-Compass	Jun 26, 2020	Substantially Equivalent	Carestream Health, Inc.
K200944	UNIEXPERT 2 PLUS	May 26, 2020	Substantially Equivalent	Adani
K193089	MULTIX Impact	Mar 20, 2020	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K193637	MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System	Jan 28, 2020	Substantially Equivalent	Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.
K193574	Q-Rad System	Jan 22, 2020	Substantially Equivalent	Carestream Health, Inc.
K193225	KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography	Jan 15, 2020	Substantially Equivalent	Konica Minolta Healthcare Americas, Inc.
K193360	Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard	Jan 02, 2020	Substantially Equivalent	Radmedix, LLC
K191879	DRX-Evolution with Carestream Digital Tomosynthesis	Dec 20, 2019	Substantially Equivalent	Carestream Health, Inc.
K192079	EOSedge	Nov 27, 2019	Substantially Equivalent	Eos Imaging
K190330	DRX-Evolution/Plus with Dual Energy	Nov 04, 2019	Substantially Equivalent	Carestream Health, Inc.
K192541	DigiX FDX	Oct 16, 2019	Substantially Equivalent	Allengers Medical Systems Limited
K192453	DIAMOND-5A/6A/8A	Oct 01, 2019	Substantially Equivalent	DRGEM Corporation
K192364	GXR-Series Diagnostic X-Ray System	Sep 26, 2019	Substantially Equivalent	DRGEM Corporation
K192293	uDR 592h, uDR 596i	Sep 12, 2019	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K191699	Discovery XR656 HD with VolumeRad	Jul 24, 2019	Substantially Equivalent	Ge Hualun Medical Systems Co. , Ltd.
K191418	Multix Fusion Max	Jun 19, 2019	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K190601	MasteRad MX30	Apr 25, 2019	Substantially Equivalent	Medicatech USA
K183541	ProRad 2FC and ProRad 3NC Stationary Radiographic Systems	Jan 24, 2019	Substantially Equivalent	Prognosys Medical Systems Private Limited
K182517	MULTIX Impact	Jan 11, 2019	Substantially Equivalent	Siemens Medi Cal Solutions, Inc.
K182183	GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A	Dec 07, 2018	Substantially Equivalent	Samsung Electronics Co., Ltd.
K182134	ARiX RAD Radiographic System	Nov 26, 2018	Substantially Equivalent	Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.
K182880	Halifax Imaging Kit	Oct 31, 2018	Substantially Equivalent	Halifax Biomedical, Inc.
K182647	GC70	Oct 24, 2018	Substantially Equivalent	Samsung Electronics Co., Ltd.
K182622	GU60A, GU60A-65	Oct 23, 2018	Substantially Equivalent	Samsung Electronics Co., Ltd.
K181629	GC85A	Jul 20, 2018	Substantially Equivalent	Samsung Electronics Co., Ltd.
K181413	uDR 592h, uDR 596i	Jun 27, 2018	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K181279	Ysio Max	Jun 13, 2018	Substantially Equivalent	Siemens Medi Cal Solutions, Inc.
K180543	GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85	May 24, 2018	Substantially Equivalent	Samsung Electronics Co., Ltd.
K180663	LaVid FMTS DIAGNOSTIC X-RAY SYSTEM	May 18, 2018	Substantially Equivalent	Livermoretech, Inc.
K180765	Televere Podiatry X-Ray System HF	Apr 20, 2018	Substantially Equivalent	Televere Systems, Inc.
K173517	RADspeed fit	Mar 30, 2018	Substantially Equivalent	Shimadzu Corporation
K173823	Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System	Feb 09, 2018	Substantially Equivalent	Summit Industries, LLC
K173953	uDR 780i	Jan 26, 2018	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K173828	GU60A & GU60A-65	Jan 12, 2018	Substantially Equivalent	Samsung Electronics Co., Ltd.
K173612	Optima XR646 HD	Dec 11, 2017	Substantially Equivalent	Ge Hualun Medical Systems Co. , Ltd.
K172229	GC85A	Nov 22, 2017	Substantially Equivalent	Samsung Electronics Co., Ltd.
K172869	Discovery XR656 HD	Oct 20, 2017	Substantially Equivalent	Ge Hualun Medical Systems Co. , Ltd.
K162529	DigiX FDX	Mar 03, 2017	Substantially Equivalent	Allengers Medical Systems Limited
K160857	HF 718BD X-Ray System	Feb 24, 2017	Substantially Equivalent	Arquilla, Inc. Dba X-Cel X-Ray Corporation
K163410	DigitalDiagnost C50	Jan 04, 2017	Substantially Equivalent	Philips Healthcare (Suzhou) Co., Ltd.
K163203	Carestream DRX-Evolution	Dec 13, 2016	Substantially Equivalent	Carestream Health, Inc.
K163115	GC70	Dec 07, 2016	Substantially Equivalent	Samsung Electronics Co., Ltd.
K152813	FS-500DDR Medical Radiographic X-Ray System	Dec 02, 2016	Substantially Equivalent	Orich Medical Equipment (Tianjin) Co., Ltd.
K162971	Multix Fusion Max	Nov 22, 2016	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K161937	CuattroDR	Oct 06, 2016	Substantially Equivalent	Cuattro, LLC
K162224	ArtPix Mobile EZ2GO	Sep 22, 2016	Substantially Equivalent	Cmt Medical Technologies, Ltd.
K152294	FDR Visionary Suite	Jul 15, 2016	Substantially Equivalent	Shimadzu Corporation
K160997	GC85A	Jul 06, 2016	Substantially Equivalent	Samsung Electronics Co., Ltd.
K152244	RADspeed Pro	Jun 20, 2016	Substantially Equivalent	Shimadzu Corporation
K160620	Visaris Vision® (Vision C, Vision U. Vision V, Vision X)	Mar 30, 2016	Substantially Equivalent	Visaris D.O.O. Belgrade
K153119	Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography SystemAmrad Medical FRS Digital Radiography System,	Mar 14, 2016	Substantially Equivalent	Summit Industries, LLC
K152767	OTC12D AUTO RADIOGRAPHIC SYSTEM	Dec 14, 2015	Substantially Equivalent	Del Medical, Inc.
K152788	EOS System	Oct 21, 2015	Substantially Equivalent	Eos Imaging
K151924	Q-Rad Radiographic System with Auto-Tracker Option	Aug 07, 2015	Substantially Equivalent	Quantum Medical Imaging Divison of Carestream
K151219	Models 2200DR and 1600DR Digital Stationary Radiographic Systems	Aug 04, 2015	Substantially Equivalent	Beijing Polycon Medical Engineering Company
K151685	GUA60A, GU60A-65	Jul 17, 2015	Substantially Equivalent	Samsung Electronics Co., Ltd.
K151419	GF50A	Jun 23, 2015	Substantially Equivalent	Samsung Electronics Co., Ltd.
K150725	Visaris Avanse	Jun 08, 2015	Substantially Equivalent	Visaris D.O.O. Belgrade
K150816	Jumong Series	May 08, 2015	Substantially Equivalent	Sg Healthcare Co, Ltd.
K150663	Diagnostic X-ray System	May 07, 2015	Substantially Equivalent	Osko, Inc.
K142930	Exam Vue DR	Apr 17, 2015	Substantially Equivalent	Jpi Healthcare Co, Ltd.
K150506	ELIAN Digital Diagnostic X-ray System	Apr 08, 2015	Substantially Equivalent	Osko, Inc.
K150165	GC85A	Apr 02, 2015	Substantially Equivalent	Samsung Electronics Co., Ltd.
K141837	DRX-EVOLUTION	Mar 11, 2015	Substantially Equivalent	Carestream Health, Inc.
K143270	Optima XR646	Feb 18, 2015	Substantially Equivalent	Ge Hualun Medical Systems Co. , Ltd.
K143257	KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic System	Feb 06, 2015	Substantially Equivalent	Medicatech USA
K143029	Digital Diagnostic X-ray System (GC80)	Feb 04, 2015	Substantially Equivalent	Samsung Electronics Co., Ltd.
K142773	EOS System	Jan 22, 2015	Substantially Equivalent	Eos Imaging
K133959	PODIATRY X-RAY SYSTEM	Jan 22, 2015	Substantially Equivalent	Source-Ray, Inc.
K142049	MULTIX FUSION VA30 & VA40	Dec 18, 2014	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K133496	X TWIN SYSTEM	Dec 03, 2014	Substantially Equivalent	Roesys GmbH
K133695	TITAN 11	Aug 07, 2014	Substantially Equivalent	Gemss Medical Systems Co., Ltd.
K141381	DURADIAGNOST	Jun 12, 2014	Substantially Equivalent	Philips Healthcare (Suzhou) Co., Ltd.
K140683	0180 INTUITION, 0072 PRECISION	Jun 03, 2014	Substantially Equivalent	Arcoma AB
K140326	XGEO GF50	May 29, 2014	Substantially Equivalent	Samsung Electronics Co., Ltd.
K140334	XGEO GC80	May 28, 2014	Substantially Equivalent	Samsung Electronics Co., Ltd.
K140332	XGEO GU60A	May 28, 2014	Substantially Equivalent	Samsung Electronics Co., Ltd.
K132934	MULTIX SELECT DR	Apr 10, 2014	Substantially Equivalent	Siemens Medi Cal Solutions, Inc.
K133259	YSIO MAX	Jan 24, 2014	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K132294	GALAXY AND GALAXY+PLUS DIGITAL RADIOGRAPHY SYSTEMS	Nov 12, 2013	Substantially Equivalent	Radiology Solutions, LLC
K123106	DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A	Jun 20, 2013	Substantially Equivalent	Samsung Electronics Co., Ltd.
K123105	XGEO GU60	Jun 07, 2013	Substantially Equivalent	Samsung Electronics Co., Ltd.
K122726	CPI RAD VISION	Feb 15, 2013	Substantially Equivalent	Communications & Power Industries Canada, Inc.
K123098	XGEO GC80	Jan 18, 2013	Substantially Equivalent	Samsung Electronics Co., Ltd.
K122454	FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION	Nov 20, 2012	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K122589	DFP4343C7	Oct 05, 2012	Substantially Equivalent	Mdi Consultants, Inc.
K122119	DX-D FULL LEG FULL SPINE	Sep 13, 2012	Substantially Equivalent	Afga Healthcare N.V.
K121854	SYSTEM, X-RAY, STATIONARY	Aug 22, 2012	Substantially Equivalent	Beijing Sinopharm Hundric Mediline Info. Tech. Co.
K121513	MULTIX FUSION	Aug 10, 2012	Substantially Equivalent	Siemens Medical Solution
K120752	AERODR STITCHING SYSTEM	Jun 08, 2012	Substantially Equivalent	Konica Minolta Medical & Graphic, Inc.
K121345	SR SUITE 1.0	Jun 01, 2012	Substantially Equivalent	Halifax Biomedical, Inc.
K121109	AERODR X70	May 23, 2012	Substantially Equivalent	Konica Minolta Medical & Graphic, Inc.
K120034	RADIOGRAPHIC X-RAY SYSTEM	Apr 17, 2012	Substantially Equivalent	Orich Medical Equipment (Tianjin Co., Ltd.
K113855	PANORAD, PANORAD SL	Jan 25, 2012	Substantially Equivalent	Imix Adr Finland OY
K113248	AERODR SYSTEM WITH P-21	Jan 17, 2012	Substantially Equivalent	Konica Minolta Medical & Graphic, Inc.
K111655	FLAATZ 760	Nov 30, 2011	Substantially Equivalent	Drtech Corp.
K112670	DX-D 600	Oct 27, 2011	Substantially Equivalent	Agfa Healthcare N.V.
K110828	DDRELEMENT	Aug 23, 2011	Substantially Equivalent	Swissray Medical AG
K103448	BRIVO XR385	Aug 12, 2011	Substantially Equivalent	Ge Medical Systems, LLC
K101779	CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM	May 16, 2011	Substantially Equivalent	Jpi Healthcare Co, Ltd.
K110849	PRESTODR 4143	Apr 26, 2011	Substantially Equivalent	Cmt Medical Technologies, Ltd.
K102123	VIZION DR	Jan 24, 2011	Substantially Equivalent	Viztek, Inc.
K102285	KRYSTALRAD (ATAL8)	Jan 03, 2011	Substantially Equivalent	Medicatech USA
K102284	KRYSTALRAD 560 (FLAATZ 560)	Jan 03, 2011	Substantially Equivalent	Medicatech USA
K102408	DIGITAL DIAGNOSTIC X-RAY SYSTEM	Dec 27, 2010	Substantially Equivalent	DRGEM Corporation
K102349	AERODR SYSTEM	Nov 24, 2010	Substantially Equivalent	Konica Minolta Medical & Graphic, Inc.
K103050	DX-D 300	Oct 29, 2010	Substantially Equivalent	Agfa Healthcare N.V.
K101686	FDR IMAGE STITCHING OPTION	Oct 29, 2010	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K101042	BLADEVIEW	Oct 29, 2010	Substantially Equivalent	Accogent, LLC
K102680	Z-MOTION DIGITAL DIAGNOSTIC X-RAY SYSTEM	Oct 22, 2010	Substantially Equivalent	Control-X Medical, Inc.
K093816	DIGITAL RADIOGRAPHY SYSTEM, MODELS GALAXY 900 AND 1600	Oct 05, 2010	Substantially Equivalent	Medien International Co, Ltd.
K101435	IMIX PANORAD AND SOMARAD	Sep 15, 2010	Substantially Equivalent	Imix Adr Finland OY
K092830	DIGITAL X-RAY IMAGING SYSTEM, MODEL DRC-1000	Jul 21, 2010	Substantially Equivalent	VATECH Co., Ltd.
K091752	VIZTEK WL	Nov 12, 2009	Substantially Equivalent	Viztek, Inc.
K092307	IMASIGHT 4600 DIGITAL RADIOGRAPHY SENSOR	Aug 25, 2009	Substantially Equivalent	Imasight, Inc.
K091889	DRX-EVOLUTION, MODEL VX3733-SYS	Jul 20, 2009	Substantially Equivalent	Carestream Health, Inc.
K091747	FLAATZ 500	Jul 01, 2009	Substantially Equivalent	Drtech Corp.
K083640	DIGITAL X-RAY IMAGING SYSTEM, MODEL: CXD-DR80D	Jun 29, 2009	Substantially Equivalent	Choong Wae Medical Corp.
K090279	SEDECAL, MILLENNIUM PLUS	Mar 11, 2009	Substantially Equivalent	Sedecal., Sa.
K090238	SEDECAL X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS	Feb 27, 2009	Substantially Equivalent	Sedecal., Sa.
K083503	DRAD30003/RADREX-I	Feb 13, 2009	Substantially Equivalent	Toshiba America Medical Systems, In.C
K083510	KUBTEC XPERT 20	Jan 08, 2009	Substantially Equivalent	Kub Technologies, Inc.
K083109	SUINSA DIAGNOSTIC X-RAY SYSTEM	Dec 04, 2008	Substantially Equivalent	Suinsa
K083181	QV-9000 UNIVERSAL SYSTEM	Nov 26, 2008	Substantially Equivalent	Quantum Medical Imaging, LLC
K082604	VIZTEK DR, MODELS: DR1000, DR3000, DR4000	Nov 21, 2008	Substantially Equivalent	Viztek, Inc.
K082261	DXRAD MODELS DX800 OR DX808 DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS	Nov 06, 2008	Substantially Equivalent	Dxrad Solutions , Ltd.
K082798	DIGITAL DIAGNOSTIC X-RAY SYSTEM, MODELS MAK 1500, MAK 2000 AND MAK 3000	Oct 28, 2008	Substantially Equivalent	Medicatech USA
K082064	RADVISION ET DIAGNOSTIC X-RAY SYSTEM	Aug 22, 2008	Substantially Equivalent	Almana Medical Imaging
K081722	YSIO	Aug 22, 2008	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K081836	CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM	Jul 30, 2008	Substantially Equivalent	Carestream Health, Inc.
K080614	DR VISION NEO, DR VISION DOU	Jun 20, 2008	Substantially Equivalent	Almana Medical Imaging
K080582	MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA	May 15, 2008	Substantially Equivalent	Medicatech USA
K080655	CHRYSALIS	May 09, 2008	Substantially Equivalent	Meta Imaging Solutions, LLC
K080553	DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16	Apr 16, 2008	Substantially Equivalent	Vieworks Co., Ltd.
K073650	FUJIFILM UNITY SPEEDSUITE, MODEL CR-IR 371	Feb 06, 2008	Substantially Equivalent	Fujifilm Medical Systems U.S.A, Inc.
K073114	IMIX INSIGHT X-RAY SYSTEMS	Jan 17, 2008	Substantially Equivalent	Imix Adr Finland OY
K073632	INTUITION, MODEL 0170	Jan 10, 2008	Substantially Equivalent	Arcoma AB
K072867	IMIX 2000 DIGITAL RADIOGRAPHY SYSTEM, MODELS UNV 3K, UNV 3KW, UNV 4K	Nov 21, 2007	Substantially Equivalent	Imix Adr Finland OY
K072659	RAD VISION, MODELS E AND EU	Nov 15, 2007	Substantially Equivalent	Almana Medical Imaging
K071546	EOS	Sep 18, 2007	Substantially Equivalent	Biospace Med
K072010	QUANTUM DIREX SYSTEM	Aug 07, 2007	Substantially Equivalent	Quantum Medical Imaging, LLC
K071392	PXS-810, PODIATRY X-RAY SYSTEM	Aug 03, 2007	Substantially Equivalent	Source-Ray, Inc.
K071401	X3C 2200 DIGITAL RADIOGRAPHIC SYSTEM	Jun 22, 2007	Substantially Equivalent	Imaging Dynamics Company , Ltd.
K071430	SYNERAD OMNI, MODELS AN6255 AND AN6265	Jun 21, 2007	Substantially Equivalent	Analogic Corp.
K071408	X3C 1100 RADIOGRAPHIC TABLE WITH DIGITAL RADIOGRAPHIC DETECTOR	Jun 13, 2007	Substantially Equivalent	Imaging Dynamics Company , Ltd.
K071403	X3C 1600 DIGITAL RADIOGRAPHIC SYSTEM	Jun 11, 2007	Substantially Equivalent	Imaging Dynamics Company , Ltd.
K071409	X3C 1590 DIGITAL RADIOGRAPHIC SYSTEM	Jun 08, 2007	Substantially Equivalent	Imaging Dynamics Company , Ltd.
K071402	X3C 1600 PLUS DIGITAL RADIOGRAPHIC SYSTEM	Jun 08, 2007	Substantially Equivalent	Imaging Dynamics Company , Ltd.
K070678	DDRCOMPACT, DDRCOMPACT PLUS AND DDRCOMPACT CHEST	May 02, 2007	Substantially Equivalent	Swissray International, Inc.
K063247	XPLORER 1800 DIGITAL RADIOGRAPHIC SYSTEM WITH UNIVERSAL STAND	Nov 22, 2006	Substantially Equivalent	Imaging Dynamics Company , Ltd.
K063246	XPLORER 1500 DIGITAL RADIOGRAPHIC SYSTEM WITH STAND	Nov 22, 2006	Substantially Equivalent	Imaging Dynamics Company , Ltd.
K062634	ORTHOXP	Oct 06, 2006	Substantially Equivalent	Imaging Dynamics Company , Ltd.
K062417	XPLORER 1100	Sep 15, 2006	Substantially Equivalent	Imaging Dynamics Company , Ltd.
K062335	SEDECAL X PLUS LP PLUS	Sep 14, 2006	Substantially Equivalent	Sedecal., Sa.
K062405	XPLORER 1590	Sep 13, 2006	Substantially Equivalent	Imaging Dynamics Company , Ltd.
K061595	XAMINER	Aug 17, 2006	Substantially Equivalent	Imaging Dynamics Company , Ltd.
K060550	KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386	Mar 31, 2006	Substantially Equivalent	Eastman Kodak Company
K052943	DDRFORMULA AND DDRFORMULA PLUS	Dec 15, 2005	Substantially Equivalent	Swissray Medical AG
K052541	MODEL HF-50R COMPUTER CONTROLLED X-RAY SYSTEM	Nov 03, 2005	Substantially Equivalent	Avant Medical Systems
K051967	REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS	Aug 09, 2005	Substantially Equivalent	GE Healthcare
K051258	KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345	Jun 01, 2005	Substantially Equivalent	Eastman Kodak Company
K050704	MODIFICATION TO: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH IMAGE PASTING AND AUTOPOSITIONING	Apr 08, 2005	Substantially Equivalent	General Electric Co.
K033577	UNISCAN, PULMOSCAN, PULMOSCAN RADIOGRAPHIC SYSTEMS	Mar 18, 2005	Substantially Equivalent	Medlink Imaging
K050151	MULTIDIAGNOST ELEVA	Feb 09, 2005	Substantially Equivalent	Philips Medical Systems North America, Inc.
K043025	SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250	Nov 19, 2004	Substantially Equivalent	Analogic Corp.
K042876	URS LP DIGITAL, MILLENNIUM, RADPRO	Nov 18, 2004	Substantially Equivalent	Sedecal., Sa.
K040995	SYNERAD MULTI DIGITAL X-RAY SYSTEM, MODEL AN6150	May 25, 2004	Substantially Equivalent	Analogic Corp.
K033345	AN5150 AND AN7150 DIGITAL RADIOLOGY SYSTEMS	Nov 19, 2003	Substantially Equivalent	Analogic Corp.
K031535	PHILIPS EASYDIAGNOST ELEVA	Jun 17, 2003	Substantially Equivalent	Philips Medical Systems North America Co.
K023008	UNIVERSAL SYSTEM, MODEL QV-800	Nov 13, 2002	Substantially Equivalent	Quantum Medical Imaging, LLC
K022737	HCMI X-RAY HIGH REQUENCY CHIROPRACTIC RADIOGRAPHIC	Oct 22, 2002	Substantially Equivalent	Health Care Mfg., Inc.
K022667	HCMI X-RAY	Oct 22, 2002	Substantially Equivalent	Health Care Mfg., Inc.
K013826	AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM)	Feb 01, 2002	Substantially Equivalent	Siemens Medical Systems, Inc.
K013481	DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION	Nov 02, 2001	Substantially Equivalent	GE Medical Systems
K012546	OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM	Nov 02, 2001	Substantially Equivalent	Sedecal USA, Inc.
K012165	OLDELFT THORASCAN MODEL NUMBER 180T	Sep 19, 2001	Substantially Equivalent	Nucletron Corp.
K012389	REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM	Aug 10, 2001	Substantially Equivalent	Ge Medical Systems, Inc.
K011486	Q-RAD RADIOGRAPHIC SYSTEM	Jun 20, 2001	Substantially Equivalent	Quantum Medical Imaging, LLC
K011111	MXD100/MX 20, OR MX 30, OR MX 40 OR MX 50--(MXD 100 SERIES)	May 30, 2001	Substantially Equivalent	Modular X-Ray Devices
K001341	DR5000 DEDICATED CHEST X-RAY SYSTEM	Jun 02, 2000	Substantially Equivalent	Analogic Corp.
K001336	DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEM	Jun 02, 2000	Substantially Equivalent	Analogic Corp.
K001201	MULTIX COMPACT K AND MULTIX L RADIOGRAPHIC X-RAY SYSTEMS	Jun 01, 2000	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K993962	PENSIL TRAUMA, MODEL WWS6100	Dec 21, 1999	Substantially Equivalent	Wuestec Medical, Inc.
K993665	LEGEND CRF FLUORO AND RAD SYSTEM	Nov 12, 1999	Substantially Equivalent	Ge Medical Systems, Inc.
K993090	SILHOUETTE FC	Oct 01, 1999	Substantially Equivalent	Ge Medical Systems, Inc.
K992066	REVOLUTION TX/I DIGITAL RADIOGRAPHIC TABLE SYSTEM	Aug 30, 1999	Substantially Equivalent	GE Medical Systems
K990715	SHIMADZU CEILING TUBE SUPPORT CH-30GH	Apr 16, 1999	Substantially Equivalent	Shimadzu Corp.
K990298	TOPOGRAPHIC IMAGING MARKER	Mar 03, 1999	Substantially Equivalent	I.Z.I. Medical Products Corp.
K990242	TOPOGRAPHIC IMAGING MARKER	Mar 03, 1999	Substantially Equivalent	I.Z.I. Medical Products Corp.
K984111	FV-RF	Dec 11, 1998	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K982955	SILHOUETTE VR	Nov 04, 1998	Substantially Equivalent	GE Medical Systems
K982824	X-RAY TIMER MODEL I.E.D. 7888 I.D. 7881 AND B764ID	Oct 29, 1998	Substantially Equivalent	I.E.D., Inc.
K981880	DX-480, ADD ON DIGITAL IMAGER	Oct 20, 1998	Substantially Equivalent	Wuestec Medical, Inc.
K982196	DIGITAL RADIOGRAPHIC IMAGING SYSTEM	Oct 06, 1998	Substantially Equivalent	GE Medical Systems
K981657	PHILIPS THORAVISION	Jun 18, 1998	Substantially Equivalent	Philips Medical Systems North America, Inc.
K981056	VARIAN XIMATRON SCAN VISION CT	Jun 12, 1998	Substantially Equivalent	Varian Medical Systems, Inc.
K980296	OLDELFT DIGIDELCA	Apr 17, 1998	Substantially Equivalent	Oldelft Corp. of America
K974863	IMIX DIGITAL THORAX SYSTEM	Mar 17, 1998	Substantially Equivalent	Advanced Instrument Development, Inc.
K974597	ADC COMPACT (AGFA DIAGNOSTIC CENTER)	Mar 09, 1998	Substantially Equivalent	Bayer Corp., Agfa Div.
K974112	VACUDAP, MODEL 2000, 2001	Jan 29, 1998	Substantially Equivalent	Victoreen, Inc.
K973710	DIGITAL ADD ON MULTI SYSTEM	Dec 18, 1997	Substantially Equivalent	Swissray International, Inc.
K970136	DIGITAL ADD-ON BUCKY	Nov 21, 1997	Substantially Equivalent	Swissray Teleray AG
K973219	AMBER DU	Oct 08, 1997	Substantially Equivalent	Oldelft Corp. of America
K972766	PIVOTING COMPENSATING FILTERS FOR THE HEAD	Aug 14, 1997	Substantially Equivalent	Octostop, Inc.
K972000	X-RAY ASSIST BAR	Jul 08, 1997	Substantially Equivalent	Ralph Lindel, D.C.
K963941	THE PHARAOH COMPENSATING FILTER	Nov 27, 1996	Substantially Equivalent	Octostop, Inc.
K962896	KODAK DIGITAL SCIENCE REMOTE CASSETTE	Sep 20, 1996	Substantially Equivalent	Eastman Kodak Company
K954196	UNIVERSIX 120	Oct 24, 1995	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K953832	SOLARIX FV	Sep 12, 1995	Substantially Equivalent	GE Medical Systems
K952871	RIDGES PLUS	Jul 20, 1995	Substantially Equivalent	Octostop, Inc.
K952672	VERTICAL INTEGRATED PERFECT VIEW (VIP) RADIOGRAPHIC SYSTEM	Jul 13, 1995	Substantially Equivalent	Bennett X-Ray Corp.
K950980	FAST FIND GRID	May 11, 1995	Substantially Equivalent	Webb Research, Inc.
K933512	UPSCAN	Apr 19, 1995	Substantially Equivalent	Merlin Engineering Works, Inc.
K944613	SHOULDER RETRACTOR	Jan 18, 1995	Substantially Equivalent	Northwest Medical Physics Center
K945709	SII 525 MS	Dec 14, 1994	Substantially Equivalent	Scott Imaging Intl., Inc.
K945708	SII 360 MS	Dec 14, 1994	Substantially Equivalent	Scott Imaging Intl., Inc.
K945278	PHILIPS BUCKY DIAGNOST FAMILY	Dec 14, 1994	Substantially Equivalent	Philips Medical Systems North America, Inc.
K942581	BES - BREATH EXPOSURE SYNCHRONIZER	Dec 12, 1994	Substantially Equivalent	The Henry G. Dietz Co., Inc.
K936087	CARPAL BOX	Oct 20, 1994	Substantially Equivalent	Innovative Medical Technologies, Inc.
K931071	PHILIPS THORAVISION	Sep 15, 1994	Substantially Equivalent	Philips Medical Systems, Inc.
K940306	OCTOSTOP COMPENSATING FILTERS	Sep 06, 1994	Substantially Equivalent	Octostop, Inc.
K942792	BUCKY STAND BR-10M	Jul 29, 1994	Substantially Equivalent	Shimadzu Corp.
K941592	WEIGHT BAG	Jun 06, 1994	Substantially Equivalent	Biocor, Inc.
K941931	DIAGNOSTIC X-RAY PATIENT EXPOSURE INDICATOR	May 26, 1994	Substantially Equivalent	Victoreen, Inc.
K935649	WHIS-RAD TUBSTAND STRUCTURE/MOBILE PATIENT TROLLEY	Feb 09, 1994	Substantially Equivalent	Bennett X-Ray Corp.
K933778	WHITMORE ANKLE X-RAY EXTENSION (AXE)	Dec 13, 1993	Substantially Equivalent	Whitmore Ent., Inc.
K934005	SHIMADZU CEILING TUBE SUPPORT CH-30GX	Nov 24, 1993	Substantially Equivalent	Shimadzu Corp.
K934755	FAST FIND GRIND	Nov 19, 1993	Substantially Equivalent	Webb Research Ii, Inc.
K933023	CERVICAL TRACTION STRAP	Sep 20, 1993	Substantially Equivalent	Cook (Canada), Inc.
K926554	525 SFQ X-RAY CONTROL W/HIGH VOLTAGE GENERATOR	May 17, 1993	Substantially Equivalent	Tingle X-Ray Products, Inc.
K920347	TOP-X 650HF RADIOGRAPHIC X-RAY	May 17, 1993	Substantially Equivalent	Control-X, Inc.
K921112	FUJI COMPUTED RADIOGRAPHY OD-F623 OPTICAL-DISK	Apr 27, 1993	Substantially Equivalent	Fujifilm Medical System U.S.A., Inc.
K926069	WRIST TRACTION	Jan 21, 1993	Substantially Equivalent	Octostop, Inc.
K923455	HFG 350, 650, 1050	Dec 28, 1992	Substantially Equivalent	Varian Canada, Inc.
K913435	PXI URCD	Nov 05, 1992	Substantially Equivalent	Brotherston/Pxi
K913711	GENTLE SLOPE	Oct 14, 1992	Substantially Equivalent	Octostop, Inc.
K913659	LITTLE PRISM	Oct 14, 1992	Substantially Equivalent	Octostop, Inc.
K922813	GEN-X 800-400 -- MODIFICATION	Aug 11, 1992	Substantially Equivalent	Swiss Ray Medical Systems
K921539	GEN-X 800/6/50	Aug 11, 1992	Substantially Equivalent	Swiss Ray Medical Systems
K915362	VORTECH'S FILM DIGITIZER, FD-1	Apr 06, 1992	Substantially Equivalent	Vortech Data, Inc.
K920558	KONICA DIRECT DIGITIZER KD-1000	Mar 06, 1992	Substantially Equivalent	Konica Corp.
K913757	HOLOGIC CER 20/20, COMPUTED EQUAL RADIO DIAG CHEST	Oct 30, 1991	Substantially Equivalent	Hologic, Inc.
K912517	FLOOR MOUNT TUBESTAND PERFORMER, 6610.101/S-9109	Sep 19, 1991	Substantially Equivalent	Continental X-Ray Corp.
K912515	FLOOR MOUNT TUBESTAND-PERFORMER-N 6610.102/S-9110	Sep 19, 1991	Substantially Equivalent	Continental X-Ray Corp.
K910757	THE BULLION	Sep 16, 1991	Substantially Equivalent	Octostop, Inc.
K904676	NDI MODEL IRS-TD	Jun 21, 1991	Substantially Equivalent	National Diagnostic Imaging, Inc.
K904147	HUGH YOUNG II UROLOGICAL X-RAY SYSTEM	Dec 13, 1990	Substantially Equivalent	Mallinckrodt Group, Inc.
K904146	NEURO VISION RADIOGRAPHIC X-RAY SYSTEM	Dec 13, 1990	Substantially Equivalent	Mallinckrodt Group, Inc.
K904145	HYDRA VISION UROLOGICAL X-RAY SYSTEM	Dec 13, 1990	Substantially Equivalent	Mallinckrodt Group, Inc.
K902791	G.E. 48-4 CEILING TUBEHANGER	Oct 29, 1990	Substantially Equivalent	Electromek Diagnostic Systems, Inc.
K902606	RADIOPAQUE RULER	Sep 27, 1990	Substantially Equivalent	Professional Medical Services
K902378	CARDIOTHORACIC RULER	Jun 14, 1990	Substantially Equivalent	Devcom, Inc.
K900562	TRANS X 100 CHEST FILM CHANGER	Apr 10, 1990	Substantially Equivalent	Acoma Medical Imaging, Inc.
K884477	SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B	Mar 15, 1989	Substantially Equivalent	Shimadzu Precision Instruments, Inc.
K883834	MEDRAD OMNIPLANE 300 SYSTEM	Nov 04, 1988	Substantially Equivalent	Medrad, Inc.
K883160	CATAPULT BUCKY (KATAPULT BLENDA)	Sep 08, 1988	Substantially Equivalent	Bay X-Ray, Inc.
K880352	MTX GENERATOR	Jul 14, 1988	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K880982	ORALIX PAN DC III CEPH OR PANORAMIC MODE ONLY	Jun 06, 1988	Substantially Equivalent	Orion Corporation Soredex
K872525	A.L.A.R.M. (ADJUST. LEG & ANKLE REPOSITIONING MECH	Feb 22, 1988	Substantially Equivalent	M.C. Johnson Co., Inc.
K872317	BC 1800 FINGER POSITIONER	Aug 12, 1987	Substantially Equivalent	Instrumentation Industries, Inc.
K872316	BC 1400 HAND POSITIONER	Aug 12, 1987	Substantially Equivalent	Instrumentation Industries, Inc.
K872468	JOVI MYELOGRAPHY HARNESS	Jul 01, 1987	Substantially Equivalent	Jovi, Inc.
K870400	SCX INFORMATION MANAGEMENT SYSTEM	Jun 18, 1987	Substantially Equivalent	General Electric Co.
K870300	BELMONT, PODIATRY X-RAY - REMEX, MODEL PD75	Mar 25, 1987	Substantially Equivalent	Belmont Equipment Corp.
K863309	REFURBISH DIAGNOSTIC X-RAY EQUIPMENT	Jan 16, 1987	Substantially Equivalent	Chemarts and Assoc., Inc.
K862616	AMBER-CHEST	Sep 02, 1986	Substantially Equivalent	Old Delft Corp. of America
K861994	MODEL RS-3I RADIOGRAPHIC/FLUROSCOPIC X-RAY SYSTEM	Jul 18, 1986	Substantially Equivalent	Medicor USA , Ltd.
K860025	MODEL MS-325 RADIOGRAPHIC X-RAY GENERATOR	May 07, 1986	Substantially Equivalent	Medicor USA , Ltd.
K854110	KEITHLEY MODEL 75100 & 75200	Mar 06, 1986	Substantially Equivalent	Keithley Instruments, Inc.
K855161	UPRIGHT BUCKY STAND/MOUNT	Feb 12, 1986	Substantially Equivalent	X-Ray Systems
K853330	BOOMERANG ABSORPTION COMENSATION FILTER	Nov 15, 1985	Substantially Equivalent	Entreprises Octostop, Inc.
K853753	DIAMENTOR PATIENT X-RAY EXPOSURE INDICATOR 07302	Oct 02, 1985	Substantially Equivalent	Victoreen, Inc.
K852349	RHYNOSTAT H-12 & V-22	Sep 03, 1985	Substantially Equivalent	Remesta Medical Corp.
K841923	DCX-100 CHEST UNIT-GL-5000M	Aug 10, 1984	Substantially Equivalent	Transworld X-Ray Corp.
K841756	LIEBEL-FLARSHEIM ACS 1000 CHEST X-RAY	Jul 06, 1984	Substantially Equivalent	Syvron Corp.
K833559	ARMBOARD	Jan 03, 1984	Substantially Equivalent	Mtd, Inc.
K813173	VRT TABLE W/INTEGRATING TUBE STAND/ELEV	Dec 14, 1981	Substantially Equivalent	General Electric Co.
K812332	KERMATH L/C ARM	Sep 16, 1981	Substantially Equivalent	Kermath Mfg. Corp.
K811934	DSS 500	Aug 13, 1981	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K811807	UROSKOP C	Aug 10, 1981	Substantially Equivalent	Siemens Corp.
K811230	X-CELL X-RAY #'S P-75W/P-75M	Jun 23, 1981	Substantially Equivalent	X-Cel X-Ray Corp.
K811215	KERMATH RADIOGRAPHIC HEAD STAND	Jun 12, 1981	Substantially Equivalent	Kermath Mfg. Corp.
K811142	BELMONT PODIATRY MODEL 065 X-RAY	Jun 09, 1981	Substantially Equivalent	Belmont Equipment Corp.
K810973	SYSTEM 400	May 21, 1981	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K810797	LOW DOSE SERVOCHEST	Apr 14, 1981	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K803049	DIGITAL RADIOGRAPHY CHEST DEVICE	Mar 02, 1981	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K803130	MULTIX U. BUCKY TABLE X-RAY UNIT	Jan 28, 1981	Substantially Equivalent	Siemens Corp.
K802200	VERTIX 3D-U	Oct 23, 1980	Substantially Equivalent	Siemens Corp.
K800788	SIREGRAPH C	May 14, 1980	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K800564	GENERAL ELECTRIC RADVIEW MARK I SYSTEM	May 02, 1980	Substantially Equivalent	General Electric Co.
K791374	THE MTD VARA SET CASETTE HOLDER	Sep 07, 1979	Substantially Equivalent	Mtd, Inc.
K790741	COMPACT SYSTEM	Apr 26, 1979	Substantially Equivalent	Pausch Corp.
K790740	BS 66, UNIVERSAL BUCKY STAND	Apr 26, 1979	Substantially Equivalent	Pausch Corp.
K790685	POSI-TOT	Apr 23, 1979	Substantially Equivalent	Victoreen, Inc.
K790070	SIREGRAPH B-150	Jan 26, 1979	Substantially Equivalent	Siemens Corp.
K790069	BUCKYMAT	Jan 26, 1979	Substantially Equivalent	Siemens Corp.
K781983	EXPLORAMAT, COSMIC 2	Dec 04, 1978	Substantially Equivalent	Siemens Corp.
K781613	SIREMAT	Oct 03, 1978	Substantially Equivalent	Siemens Corp.
K781473	BUCKY WALL STAND	Sep 11, 1978	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K771051	C-ARM X-RAY SYSTEM	Jun 24, 1977	Substantially Equivalent	General Electric Co.
K770060	X-RAY POSITIONING DEVICE	Jan 24, 1977	Substantially Equivalent	Robert R. Moore
K760205	RADIOGRAPHIC UNIT, XRC-1	Jul 26, 1976	Substantially Equivalent	Xrc, Inc.